Systems and Methods for Monitoring Operations of an Infusion Delivery Device Using a Pressure Sensor

Abstract

The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of: (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

1 .- 20 . (canceled) 
     
     
         21 . An infusion delivery device comprising:
 a fluid reservoir configured to hold a therapeutic fluid;   at least one pressure sensor configured to measure a change of pressure in the fluid reservoir; and   one or more processors in communication with the at least one pressure sensor and a non-transitory computer-readable medium having encoded thereon instructions that, when executed by the one or more processors, cause the one or more processors to:
 receive pressure data from the at least one pressure sensor indicative of the change in pressure in the fluid reservoir due to addition of the therapeutic fluid to the fluid reservoir; 
 based on the pressure data, registering a fill event when at least a portion of the fluid reservoir is filled with the therapeutic fluid and associating the fill event with a first time; and 
 prevent or allow operation of the infusion delivery device at a second time based on a predetermined difference between the second time and the first time. 
   
     
     
         22 . The infusion delivery device of  claim 21 , wherein a time stamp is saved in memory during the fill event. 
     
     
         23 . The infusion delivery device of  claim 21 , wherein the at least one pressure sensor interfaces with a distal end of the fluid reservoir. 
     
     
         24 . The infusion delivery device of  claim 21 , wherein the instructions, when executed by the one or more processors, cause the one or more processors to alert a user based on a predefined error code corresponding to an amount of time the infusion delivery device is in use. 
     
     
         25 . The infusion delivery device of  claim 21 , wherein the instructions, when executed by the one or more processors, cause the one or more processors to transmit one or more notifications to a user to alert the user of an amount of time the infusion delivery device has remaining to be in use. 
     
     
         26 . The infusion delivery device of  claim 21 , wherein a threshold value of the fill event is pre-programmed in the non-transitory computer-readable medium. 
     
     
         27 . The infusion delivery device of  claim 21 , wherein a threshold value of the fill event is based on a sum of a pre-defined base pressure and a pressure measurement from the at least one pressure sensor when the infusion delivery device is first paired to a controller. 
     
     
         28 . The infusion delivery device of  claim 21 , wherein a threshold value of the fill event is driven by an amount of pressure required to push a plunger through the fluid reservoir. 
     
     
         29 . The infusion delivery device of  claim 21 , wherein the predetermined difference between the second time and the first time corresponds to an expiration time or a degradation time of one or more of the infusion delivery device or the therapeutic fluid. 
     
     
         30 . A method comprising:
 monitoring a pressure in a fluid reservoir of an infusion delivery device as a therapeutic fluid is being added to the fluid reservoir;   when at least a portion of the fluid reservoir is filled with the therapeutic fluid, registering a fill event occurring at a first time based on the monitored pressure; and   preventing or allowing operation of the infusion delivery device at a second time based on a predetermined difference between the second time and the first time.   
     
     
         31 . The method of  claim 30 , further comprising causing one or more notifications to be transmitted to alert a user of an amount of time the infusion delivery device is in use. 
     
     
         32 . The method of  claim 30 , further comprising causing one or more notifications to be transmitted to alert a user of an amount of time the infusion delivery device has remaining to be in use. 
     
     
         33 . The method of  claim 30 , wherein allowing the operation is performed during a time when a user is instructed to fill the infusion delivery device. 
     
     
         34 . The method of  claim 30 , wherein a pressure threshold of the fill event is pre-programmed in the infusion delivery device. 
     
     
         35 . The method of  claim 30 , wherein a pressure threshold of the fill event is based on a sum of a pre-defined constant and a pressure measurement when the infusion delivery device is first paired to a controller. 
     
     
         36 . The method of  claim 30 , wherein a pressure threshold of the fill event is driven by an amount of pressure required to push a plunger through the fluid reservoir. 
     
     
         37 . An infusion management system comprising:
 an infusion delivery device comprising:
 a fluid reservoir configured to hold a therapeutic fluid; 
 at least one pressure sensor configured to measure a change of pressure in the fluid reservoir; and 
 one or more processors in communication with at least one pressure sensor and a non-transitory computer-readable medium having encoded thereon instructions that, when executed by the one or more processors, cause the one or more processors to:
 receive pressure data from the at least one pressure sensor indicative of the change in pressure in the fluid reservoir due to addition of the therapeutic fluid to at least a portion of the fluid reservoir; 
 registering when a fill event has occurred at a first time based on the pressure data; and 
 prevent or allow operation of the infusion delivery device at a second time based on a predetermined difference between the second time and the first time; and 
 
 one or more controllers in communication with the infusion delivery device, wherein the one or more controllers are configured to exchange data or instructions with the infusion delivery device. 
   
     
     
         38 . The infusion management system of  claim 37 , wherein the one or more controllers comprise a user interface for communicating with a user. 
     
     
         39 . The infusion management system of  claim 37 , wherein the one or more controllers comprise a smart phone. 
     
     
         40 . The infusion management system of  claim 37 , wherein the one or more processors is configured to transmit one or more notifications to the one or more controllers. 
     
     
         41 . The infusion management system of  claim 37 , wherein the one or more controllers comprise a dedicated wireless remote controller.